Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
PHASE3
159 participants
INTERVENTIONAL
2025-03-31
2028-09-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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ESB adjunct to IAI
Single ESB treatment adjunct to intravitreal aflibercept injections (IAI)
Episcleral Brachytherapy
Minimally invasive, single fraction brachytherapy
Aflibercept Injection
Standard of Care intravitreal aflibercept injection
IAI monotherapy
Intravitreal aflibercept injections (IAI)
Aflibercept Injection
Standard of Care intravitreal aflibercept injection
Interventions
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Episcleral Brachytherapy
Minimally invasive, single fraction brachytherapy
Aflibercept Injection
Standard of Care intravitreal aflibercept injection
Eligibility Criteria
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Inclusion Criteria
* Incomplete response to anti-VEGF
* Received at least 3 consecutive and sequential anti-VEGF injections (no missed treatments)
* Ability to undergo ESB intervention
Exclusion Criteria
* Type I or Type II diabetes mellitus
* Previous therapeutic radiation to the head or neck that may have resulted in radiation dose to the retina
* Study eye with BCVA of worse than 20 ETDRS letters (20/400 Snellen)
* Fellow eye with worse BCVA than the study eye or other vision-threatening disease not eligible for treatment
* Receiving anti-VEGF therapy for any reason other than AMD
50 Years
ALL
No
Sponsors
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Salutaris Medical Devices, Inc.
INDUSTRY
Responsible Party
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Central Contacts
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Other Identifiers
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SMD-202101
Identifier Type: -
Identifier Source: org_study_id
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